Dosage forms and concentrations

injectable solution (generic formulation): 1 mg / ml (10 ml single-use vial)

Tablets: 10 mg (Mavenclad)

Hairy cell leukemia

Cladribine (parenteral only): Continuous infusion of 0.09 mg / kg / day IV for 7 days

Dosing Considerations

  • Monitor CBC with differential
  • Monitor signs/symptoms of neurotoxicity and infection; if infection present, treat as appropriate prior to therapy; if not possible, consider alternative therapy if possible

Recurrent forms of multiple sclerosis

Mavenclad only

  • Include relapsing-remitting disease and active secondary progressive disease
  • In general, its use is recommended for patients with an inadequate response or who cannot tolerate the indicated alternative drug.
  • 2 annual treatment cycles: 1.75 mg / kg / cycle PO; each course divided into 2 treatment cycles; without exceeding the cumulative dose of 3.5 mg / kg (see oral administration)
  • Oral dose per cycle by weight in each treatment cycle

 

  1. See also Administration for the timing of each cycle and treatment cycle.
  2. <40 kg: safety and efficacy not established
  3. 40 kg to <50 kg: first cycle of 40 mg; 40 mg second cycle
  4. 50 kg to <60 kg: 50 mg first cycle; 50 mg second cycle
  5. 60 kg to <70 kg: first cycle 60 mg; 60 mg second cycle
  6. 70 kg to <80 kg: first cycle 70 mg; 70 mg second cycle
  7. 80 kg to <90 kg: first cycle of 80 mg; 70 mg second cycle
  8. 90 kg to <100 kg: first cycle of 90 mg; 80 mg second cycle
  9. 100 kg to <110 kg: first cycle of 100 mg; 90 mg second cycle
  10. ≥110 kg: first cycle of 100 mg; 100 mg second cycle
  11. Do not administer> 2 tablets a day; administer 1-2 tablets / day orally for 4-5 consecutive days

Orphan designations

  • Non-Hodgkin’s lymphoma
  • AML
  • Chronic lymphocytic leukemia

Orphan Sponsor

Ortho Biotech Oncology Research & Development, Unit of J & J Pharmaceutical Research & Dev., LLC; 920 Route 202 South, P.O. Box 300; Raritan, NJ 08869-0602

Other uses

Off-label: cutaneous T-cell lymphoma, AML, CLL, NHL, autoimmune hemolytic anemia, mycosis fungoides, Sezary syndrome

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